Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ACLEXA
Active substances:
Estonian, English, Latin
ATC code: M01AH01
Dosage form: capsule, hard
Strength: 200mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated November 30, 2021)
Package information leaflet (PIL): EST  (last updated August 9, 2023)
Labelling:  (last updated August 9, 2023)
Indication: is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Safety features: Yes
Marketing authorization holder: Ideal Trade Links UAB 
Marketing authorization number: 1047921 
Marketing authorization issued on: November 30, 2021 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Assessment report:  (last updated January 8, 2014) 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1861343  ACLEXA  capsule, hard  200mg 10TK  Prescription        Poola  Poola pakend 
1861354  ACLEXA  capsule, hard  200mg 20TK  Prescription        Poola  Poola pakend 
1861365  ACLEXA  capsule, hard  200mg 30TK  Prescription  100% 50%  13,20  29.05.2024  Poola  Poola pakend 
1861376  ACLEXA  capsule, hard  200mg 40TK  Prescription        Poola  Poola pakend 
1861387  ACLEXA  capsule, hard  200mg 50TK  Prescription        Poola  Poola pakend 
1861411  ACLEXA  capsule, hard  200mg 100TK  Prescription        Poola  Poola pakend 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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